U.S. health chiefs have told the public to immediately stop using a lateral flow Covid test, which the UK has spent around £ 2.8 billion on.
Kits made by Innova were the focus of the twice-weekly smear flash in the UK, with ministers hoping the regular testing program would thwart the spread of the coronavirus.
But the tests, which revolve around nasal swabs and give results in just 30 minutes, have become a source of great controversy since they were given the green light.
Now the Food and Drug Administration (FDA), which regulates medical devices used in the United States, has shown it has “significant concerns” about the accuracy of the test and has urged Americans who bought it to throw it in the trash can .
Prominent critics of the kits said the move was “worrying”. The UK health authorities have yet to respond to MailOnline.
Innova’s controversial tests provide quick results, but experts have raised concerns about their accuracy rates, which some believe could be as low as 2 percent
The FDA urged Americans to stop using the tests and “destroy” them or return the tests to Innova
The agency accused Innova of making “false or misleading” claims about how the tests worked, with the Californian firm claiming they were 98.98 percent accurate.
Innova Medical Group is owned by private equity firm Pasaca Capital Inc, founded by Chinese-born American businessman Charles Huang (pictured)
SCIENTISTS urge the government to stop using INNOVA TEST
Scientists have accused the government of misleading the public about the accuracy of Innova’s rapid test and called for its use to be stopped.
Professor Jon Deeks, Dr. Angela Raffle and Dr. Mike Gill – of the University of Birmingham, the University of Bristol and a former Regional Director of Public Health – said in a letter published in January, “The Innova Lateral Flow Test is not suitable” for many of the government’s proposed uses.
“In the Liverpool pilot, 60 percent of people failed the test and most worried about 30 percent of those with very high viral loads who are at the highest risk of spreading the virus to others.
“An incorrect test result can lead people to take the wrong measures and expose themselves and others to the risk of infection. This can increase, not decrease, the spread of disease, sickness and death. ‘
They said the test’s limits were not made clear by the Department of Health and that it has been labeled as more accurate than it is and has been compared in some places to the much more reliable PCR tests.
While lateral flow testing has some advantages, they argued, the way it was used risked too many people getting false negative results or reporting no results if they were positive.
The researchers called in their letter, “Stop the further adoption of rapid asymptomatic tests with the Innova LFD, including its use in nursing homes, schools, communities, and home self-testing by untrained people.”
A similar, but not identical, comment is available on the British Medical Journal blog.
The FDA said the figure “does not accurately reflect the performance estimates observed during clinical trials of your devices.”
It added the claim “Does not appear to be supported by clinical data,” but did not provide any clearer accuracy figures.
But real-world statistics from the UK have shown they miss up to 40 percent of infectious people. They are also less accurate when self administered which is the main way they are used in the UK.
The FDA said the accuracy of the test “Not sufficiently established” and said the company could respond with any evidence if it denied the results.
The agency started a class that I remember – the most serious kind – that asked people to discard or return the test. There was also a warning letter to Innova instructing it to stop delivering the test in the United States.
When announcing the recall, the agency said: “The FDA warns the public to discontinue the use of the Innova SARS-CoV-2 Antigen Qualitative Rapid Test for diagnostic purposes.
“The FDA has serious concerns that the test has not been adequately demonstrated to perform, which poses a health risk.
“In addition, the labeling that is distributed with certain configurations of the test includes performance information that does not accurately reflect the performance estimates observed during the clinical trials of the tests.”
In addition, the data he submitted about the test were “identical” to the information provided by other test manufacturers, which raised “significant concerns” that the accuracy of the tests had not been proven, the letter said.
In its letter to Innova, the FDA said it had inspected the company’s premises between March 15 and April 8.
It turned out that the company was selling its SARS-CoV-2 Antigen Qualitative Rapid Test in the United States without FDA approval.
The agency also urged the company to take “immediate action” to stop selling and distributing the tests in the United States.
The FDA said it had received no reports of harm or death related to the test.
It has told people that they are no longer using the tests and either “destroy” them by throwing them away or return them to Innova.
If a test incorrectly tells someone that they are not infected, people could easily spread the virus.
False positives – telling people they have the virus when they don’t – could mean people are being mistakenly told to self-isolate.
Jon Deeks, a medical testing expert at the University of Birmingham, said on Twitter that the FDA’s announcement was “a little worrying.”
A critic of the self-test policy, Professor Deeks called on the Medicines and Health Products regulator, which approves tests in the UK, for comment.
Jo Maugham, director of the Good Law Project, tweeted, “For reasons no one could quite fathom, and with no competition, we spent £ 3 billion on it.”
The Good Law Project has taken legal action against the Ministry of Health for citing it as a “failure of wholesalers” to disclose details of the contracts made during the Covid pandemic.
PCR AND LATERAL FLOW TESTS: THE KEY DIFFERENCES
A PCR test can cost more than £ 180 per person with the swab being processed in a laboratory.
The UK, on the other hand, prefers faster tests that are not laboratory-based and give a result within 15 minutes.
These rapid coronavirus tests, known as lateral flow tests, can be performed on site using portable devices.
They’re faster and cheaper than the laboratory-based PCR tests the government uses to diagnose people, but they’re less accurate.
Innova was founded last March by Pasaca Capital, a private equity firm chaired by Wuhan-born American businessman Charles Huang – the Chinese city at the epicenter of the pandemic.
Innova’s “primary” factory for manufacturing coronavirus swabs is located in Xiamen, Fujian. The company also has three manufacturing facilities in the US and plans to expand into the UK.
It was hoped that lateral flow tests would be a way out of the pandemic because they could identify asymptomatic cases and thus help limit the spread of the virus.
However, some experts have expressed concerns that they may give “false positives”.
Studies have shown that the kits are less accurate than gold standard PCR swabs, which means they can give false positive results.
Senior strategist Ben Dyson, who is an advisor to Health Secretary Matt Hancock, told colleagues in email in April that the test’s accuracy could be as low as two percent.
His concerns were based on data showing that the number of “false positives” remained the same as the number of cases in an area decreased. This means that the ratio of false positives to true positives increases.
The FDA has directed Americans to speak to their doctor if they have been tested with the Innova swab and have concerns about the results.
It advised healthcare providers to retest patients with a Covid test other than the Innova test if the test was done less than two weeks ago and they suspect the result was false.
Brits can order free tests online that contain seven swabs and can be delivered to their home or picked up from a testing site and pharmacies.
The current council of government tells people to do the tests twice a week.
Innova said in a statement that it has “worked carefully and proactively to address FDA results” and has taken some corrective action while others are underway.
“None of the inspection observations affect the conduct of the test,” said the company.
Innova said it has voluntarily recalled the products because of the labeling issues and is “confident” that it is “on track to fully meet FDA requirements”.
Graeme Tunbridge, director of devices at Medicines & Healthcare Products Regulatory Agency (MHRA), said the agency has authorized NHS Test and Track to use the Innova tests as a self-test device across the UK to identify asymptomatic cases.
“The MHRA is reviewing all available information and is working closely with NHS Test and Trace to ensure that a full risk assessment is carried out as is our normal process to understand any impact on the products used in the UK.
“Patient safety is our top priority and we will issue safety information if necessary.”